Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement
- Registration Number
- NCT06590870
- Lead Sponsor
- Mount Sinai Hospital, Canada
- Brief Summary
The purpose of this feasibility clinical trial is to explore the role of intranasal fentanyl for pain associated with PICC placement in preterm infants. The primary goals are identifying whether enough infants join the study and complete the study procedures.
- Detailed Description
Infants admitted to the neonatal intensive care unit (NICU) are subjected to multiple painful procedures as part of clinical care. It is established that early and repeated exposure to pain is associated with negative consequences. However, pain management strategies continue to be underutilized in NICUs worldwide.
Placement of a PICC is a clinically essential painful procedure in infants requiring prolonged intravenous access. The procedure can cause moderate to severe pain. To date, the optimal medication for procedural analgesia during PICC placement is not known.
Intranasal fentanyl has emerged as an option for pain management in infants admitted to the NICU. In preparation for a future definitive clinical trial, this is a feasibility clinical trial exploring the role of intranasal fentanyl for procedural analgesia in preterm infants undergoing PICC placement.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Infants with a gestational age at birth < 32 weeks or birth weight < 1.5 kg
- Infants considered medically appropriate for the study by the most responsible physician
- Infants with choanal atresia, nasal mucosal erosion, or epistaxis
- Infants with facial anomalies
- Infants diagnosed with genetic conditions known to affect neurological development or severe (grade ≥ III) intraventricular hemorrhage
- Infants receiving continuous intravenous infusions or scheduled enteral doses of opioids or sedatives within 12 hours of PICC placement
- Infants with cardiopulmonary instability managed with inotropes, vasopressors, phosphodiesterase enzyme inhibitors, or neuromuscular blocking agents at the time of PICC placement
- Infants prescribed strong CYP3A4 inhibitors (clarithromycin, itraconazole, ketoconazole, posaconazole, ritonavir, voriconazole) at the time of PICC placement
- Infants diagnosed with bronchopulmonary dysplasia (need for supplemental oxygen or need for ventilatory support at 36 weeks corrected gestational age)
- Infants with a previous documented adverse reaction to any formulation of fentanyl
Each eligible infant will be enrolled for one PICC placement only during the study period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intranasal normal saline plus standard of care Normal saline One dose of normal saline (volume equivalent to fentanyl 1.5 µg/kg) via a mucosal atomization device 10 minutes before the PICC placement. Standard of care includes sucrose 24% oral solution with or without non-nutritive sucking. Intranasal fentanyl plus standard of care Fentanyl One dose of fentanyl 1.5 µg/kg via a mucosal atomization device 10 minutes before the PICC placement. Standard of care includes sucrose 24% oral solution with or without non-nutritive sucking.
- Primary Outcome Measures
Name Time Method Recruitment rate 6 month study period Number of infants assessed for eligibility, number of infants approached for consent, number of enrolled infants, and number of participants completing study procedures
Completeness of data collection for pain score assessment At the needle insertion phase of the PICC placement Premature infant pain profile-revised (PIPP-R) scores using video recordings. PIPP-R scores range from 0-21 and are interpreted as no pain (score of 0), mild pain (score 1-6), moderate pain (score 7-12), and severe pain (score 13-21).
- Secondary Outcome Measures
Name Time Method Number of adverse events Up to 6 hours after intranasal intervention administration Number of apneas (cessation of breathing \> 20 seconds), number of bradycardias (heart rate \< 100 beats per minute), number of desaturations (oxygen saturation \< 80%), chest wall rigidity, escalation in ventilatory support, and need for other analgesia
Acceptability and adoption of intranasal medications Immediately after the PICC placement Survey of healthcare team members capturing experience with intranasal intervention administration, including barriers and enablers to use intranasal medications
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada